Ocular Tolerance, Skin Tolerance
Conditions
Brief summary
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
Interventions
OTHERSystane® Lid Wipes
Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning
Sponsors
NOVARTIS BIOCIENCIAS S/A
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Must sign informed consent. * Agree to adhere to the procedures and requirements of the study. * Wears makeup daily. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Pregnant or breastfeeding. * Ocular conditions as specified in protocol. * Medical conditions as specified in protocol. * Skin conditions as specified in protocol. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Contact-dermatitis Adverse Reaction | Day 21 | Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis. |
| Number of Participants With Ocular Clinical Signs and Discomfort Sensations | Day 21 | Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis. |
Countries
Brazil
Participant flow
Recruitment details
Participants were recruited from 1 study center located in Brazil.
Pre-assignment details
Thirty-five participants were enrolled in this study. This reporting group includes all enrolled participants (35).
Participants by arm
| Arm | Count |
|---|---|
| Systane Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Systane |
|---|---|
| Age, Customized Age 18-70 | 35 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Number of Participants With a Contact-dermatitis Adverse Reaction
Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.
Time frame: Day 21
Population: This analysis population includes all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Systane | Number of Participants With a Contact-dermatitis Adverse Reaction | 0 participants |
Primary
Number of Participants With Ocular Clinical Signs and Discomfort Sensations
Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.
Time frame: Day 21
Population: This analysis population includes all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Systane | Number of Participants With Ocular Clinical Signs and Discomfort Sensations | 0 participants |